Table 1.
Study | Design | Participants | Interventions | Outcomes | Allocation concealment |
Garbino et al. [15] | Double-blind | 220 patients, mixture of surgical and medical critically ill adult patients; mean age = 54 years, mean APACHE II score = 19.4, mean ICU stay = 8.4 days, mean mortality = 39.5% | Intravenous fluconazole 100 mg/day until a fungal infection developed, withdrawn from mechanical ventilation, or suspicion of a serious adverse event. Duration of study = 30 months | Hospital mortality, proportion of patients with candidaemia, other fungal infections, adverse events requiring cessation of study drug, and patients required rescue therapy using systemic amphotericin B | Adequate |
Pelz et al. [16] | Double-blind | 260 critically ill surgical adult patients; mean age = 64 years, mean APACHE III score = 64, mean ICU stay = 5 days, mean mortality = 11.5% | Loading dose of 800 mg enteral fluconazole followed by 400 mg daily (reduced to 200 mg daily if creatinine clearance <25 ml/min) until 3 days after ICU discharge, or death, or clinical decision to start systemic antifungal therapy. Duration of study = 12 months | Hospital mortality, proportion of patients with candidaemia, and fungal infections, proportion of patients requiring rescue therapy using amphotericin B, proportion of patients colonised with or infected with fluconazole-resistant fungi, and the total length of hospital stay | Adequate |
Eggimann et al. [17] | Double-blind | 43 surgical adult patients with recurrent gut perforation or anastomotic leakage; mean age = 63 years, mean APACHE II score = 13, mean hospital mortality = 39.5% | 400 mg intravenous fluconazole daily until complete resolution of the intra-abdominal disease, or development of a fungal infection requiring antifungal therapy, or adverse event related to the study drug. Duration of study = 30 months | Hospital mortality, proportion of patients with candidaemia and other fungal infection, proportion of patients with adverse events leading to cessation of study drug, proportion of patients colonised with or infected with fluconazole-resistant fungi, and the total length of hospital stay | Adequate |
Sandven et al. [18] | Double-blind | 109 high-risk surgical patients with a confirmed intra-abdominal perforation; mean age = 64 years, mean hospital mortality = 11.3% | A single dose of intravenous fluconazole 400 mg intraoperatively. Duration of study 15 months | Hospital mortality, and proportion of patients with fungal infection | Adequate |
He et al. [19] | Unclear | 45 adult patients with severe pancreatitis with at least one organ dysfunction or hyperglycaemia; mean age = 50 years, mean hospital mortality = 20% | Intravenous fluconazole 100 mg/day until no organ failure was observed. Duration of study = 60 months | Hospital mortality, proportion of patients with fungal infection, proportion of patients requiring rescue therapy using amphotericin B, and total length of hospital stay | Unclear |
Jacobs et al. [13] | Double-blind | 34 patients with septic shock from intra-abdominal sepsis; mean age = 50 years, mean APACHE II score = 18, mean ICU stay = 20 days, mean hospital mortality = 44% | Intravenous fluconazole 200 mg/day until resolution of septic shock. Duration of study = 30 months | Hospital mortality, proportion of patients with candidaemia, other fungal infection, proportion of patients requiring rescue therapy using amphotericin B, and proportion of patients colonised with or infected with fluconazole-resistant fungi | Adequate |
Ables et al. [20] | Double-blind | 119 trauma or after intra-abdominal or intra-thoracic surgery adult patients with at least one of the following: central venous catheter, total parenteral nutrition, mechanical ventilation >24 hours, or treatment with broad-spectrum antibiotics; mean age = 44 years, mean APACHE II score = 18, mean mortality = 19.3% | Either Intravenous, oral, or enteral fluconazole 800 mg loading following by 400 mg daily (doses adjusted with renal impairment); oral or enteral route was used when there was a presence of bowel sounds and no history of malabsorption. Duration of study = 26 months | Hospital mortality, proportion of patients with candidaemia, proportion of patients with adverse events leading to cessation of the study drug, proportion of patients colonised with or infected with fluconazole-resistant fungi, and total length of hospital stay | Adequate |
APACHE acute physiology and chronic health evaluation; ICU, intensive care unit.